NDC 0406-0376

Hydrocodone Bitartrate and Acetaminophen 5 mg / 300 mg tablet

On the label: SpecGx LLC.

United States: 3

Where it's made

FactoryWhereRoleLast FDA inspection
SpecGx LLCHobart, NY, United StatesMakes it and tests it No problems foundMar 13, 2020 · 6 inspections
SpecGx LLCSt. Louis, MO, United StatesMakes the active ingredient Problems found, fixed voluntarilyOct 22, 2025 · 8 inspections
SpecGx LLCGreenville, IL, United StatesMakes the active ingredient Problems found, fixed voluntarilyFeb 27, 2026 · 5 inspections

Product details

Generic drug
Acetaminophen and Hydrocodone: every company that makes it
Form
tablet, oral
Strength
5 mg / 300 mg
Approval
ANDA ANDA206718
On the market since
Mar 31, 2017
Package NDCs
0406-0376-01 0406-0376-05 0406-0376-23 0406-0376-62
Official label
DailyMed (National Library of Medicine), updated Apr 30, 2026

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